Co-ordinate and compile regulatory submissions and agency correspondence for assigned projects
Implement action plans to achieve timely approval of submissions ensuring compliance
Participate in and support project teams to achieve regulatory goals
Jobgether is acting as a job platform partnering with other companies. They utilize an AI-powered matching process to ensure fair application reviews, identifying top candidates for client companies, though final hiring decisions are managed by the client's internal team.
Implement action plans for approval of submissions.
Improve internal processes and foster relationships.
They are a company using AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Oversee the Enterprise Export Control Compliance Program and ensure adherence to applicable Export Control and Research Security regulations.
Collaborate with various departments to provide expert guidance and support for compliance initiatives.
Contribute to the organization's mission to provide patient-first care while managing risks related to export regulations.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They use AI tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses.
Generates revenue using a consultative selling approach, focusing on CE marking and supply chain assessments for medical device manufacturers.
Cultivates new business opportunities and develops long-term business partnerships within the medical device manufacturing industry.
Achieves sales targets and increases revenue by selling SGS solutions relevant to clients' businesses.
SGS is the world's leading testing, inspection and certification company, recognized as the global benchmark for sustainability, quality and integrity. With 99,600 employees across 2,600 offices and laboratories, they work to enable a better, safer, and more interconnected world.
Responsible for leading the strategic direction, management, and oversight of the organization’s regulatory compliance program.
Manage a team of compliance professionals, ensuring that the company operates in full adherence to applicable laws, regulations, and industry standards.
Drive the development and implementation of enterprise-wide compliance frameworks, oversee risk assessments, support regulatory interactions, and champion a culture of compliance across the organization.
Truelogic is a leading provider of nearshore staff augmentation services headquartered in New York. Their team of 600+ highly skilled tech professionals, based in Latin America, drives digital disruption by partnering with U.S. companies on their most impactful projects.
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees
Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.
Research and interpret state and federal reporting requirements.
Communicate changes to internal teams and customers.
Conduct quality assurance testing and compliance training.
Skyward builds software solutions for K-12 schools, helping students, teachers, and school administrators succeed. They foster a work environment with teamwork, enthusiasm, continuous improvement, and fun, offering opportunities for career growth.
Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
Own the monitoring, analysis, and interpretation of state and federal legislation, regulations, and administrative rules.
Review, redline, and propose changes to legislation and regulations and evaluate proposals for impact, compliance, and risk.
Engage directly in the legislative process alongside the Government Affairs & Public Policy team.
Proof is shaping the legal and regulatory environment surrounding digital identity, remote online notarization, future of workforce, privacy, AI governance, and fraud prevention technologies. They aim to ensure its platform remains compliant, secure, and trusted.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.
Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs.
Establish and lead the clinical operations strategy, setting departmental goals.
Promote strong cross‑functional collaboration with internal stakeholders.
McKesson delivers products to healthcare providers. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient, focused on creating an inclusive environment with strong values.
Manages schedules and coordinates events for executives.
Prepares reports and handles various administrative tasks.
Supports the executive team in achieving strategic goals.
Jobgether uses an AI-powered matching process for job applications, ensuring quick and fair reviews. They identify top candidates and share shortlists with hiring companies.